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Suppliers and packagers for gralise
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gralise
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544 | NDA | Almatica Pharma LLC | 52427-803-90 | 90 TABLET, FILM COATED in 1 BOTTLE (52427-803-90) | 2020-10-01 |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544 | NDA | Almatica Pharma LLC | 52427-804-60 | 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60) | 2023-12-31 |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544 | NDA | Almatica Pharma LLC | 52427-806-90 | 90 TABLET, FILM COATED in 1 BOTTLE (52427-806-90) | 2020-10-01 |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544 | NDA | Almatica Pharma LLC | 52427-850-60 | 60 TABLET, FILM COATED in 1 BOTTLE (52427-850-60) | 2023-12-31 |
| Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544 | NDA | Almatica Pharma LLC | 52427-890-60 | 60 TABLET, FILM COATED in 1 BOTTLE (52427-890-60) | 2023-12-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Gralise
Introduction
Gralise (gabapentin extended-release) is a prescription medication used primarily for the management of postherpetic neuralgia, a chronic pain condition following shingles. As a specialized pharmaceutical product, its supply chain involves a diverse array of manufacturing and distribution entities. This analysis explores the key suppliers involved in the production and distribution of Gralise, highlighting their roles, market positions, and the implications for pharmaceutical stakeholders.
Manufacturers of Gralise
1. Activas Pharmaceuticals
Activas Pharmaceuticals is the original developer and manufacturer of Gralise. The company specializes in the formulation and production of extended-release drug products, leveraging proprietary technology to ensure consistent delivery and bioavailability of gabapentin. Their manufacturing facilities are certified according to Good Manufacturing Practices (GMP), ensuring compliance with regulatory standards set by agencies such as the FDA.
Role & Contribution:
Activas holds the patent rights and supplies the active pharmaceutical ingredient (API) as well as the finished dosage form to distributors and healthcare providers. Their focus on advanced controlled-release technology positions them as the primary OEM (Original Equipment Manufacturer) for Gralise.
Market Position:
Active and dominant in the niche market for extended-release gabapentin formulations, Activas's global manufacturing network supports domestic and international distribution.
2. Contract Manufacturing Organizations (CMOs)
In addition to Activas, several CMOs are engaged in the production of gabapentin formulations for various pharmaceutical companies. These organizations provide formulation development, manufacturing, and packaging services under contract.
- Patheon (Thermo Fisher Scientific): Known for its comprehensive API supply chain and formulation capabilities, Patheon services multiple pharmaceutical clients interested in gabapentin or similar generics.
- Lonza: Has facilities capable of producing controlled-release formulations with strict regulatory adherence.
- Recipharm: Offers manufacturing of extended-release products in compliance with GMP standards.
Implications:
By outsourcing manufacturing to CMOs, Activas potentially ensures an extensive supply capacity and diversification, reducing risks related to production bottlenecks or disruptions.
Suppliers of Active Pharmaceutical Ingredients (API)
1. Teva Pharmaceuticals
Teva is a leading global generic drug supplier, and its API manufacturing division supplies gabapentin to various formulations worldwide. Teva’s API facilities are certified by the FDA and other regulatory bodies, ensuring high-quality production.
Supply Chain Role:
Teva’s API supplies form the backbone of numerous gabapentin products, including generics and branded formulations like Gralise.
Market Impact:
Using a well-established API supplier like Teva enhances reliability, scalability, and regulatory compliance for the manufacturing process.
2. Cipla and Dr. Reddy’s Laboratories
Both are significant API manufacturers capable of producing high-quality gabapentin. They supply APIs to various pharmaceutical companies, including those producing branded formulations like Gralise or generics.
Strategic Importance:
Their role in the supply chain mitigates dependency risks on a single supplier, ensuring price competition and supply continuity.
Distribution and Logistics
1. McKesson and Cardinal Health
Distributor giants such as McKesson and Cardinal Health are integral in ensuring the widespread availability of Gralise across healthcare settings. They handle the warehousing, logistics, and distribution to pharmacies, hospitals, and clinics.
Distribution Networks:
Both companies operate extensive distribution networks in North America, ensuring rapid replenishment and compliance with temperature and storage regulations.
2. Specialty Distributors
Given the specific patient population for Gralise, specialty distributors like Diplomat Pharmacy or Rx Therapeutics may also play roles in targeted distribution, especially within chronic pain management clinics.
Regulatory and Quality Assurance Suppliers
Suppliers involved in ensuring regulatory compliance and quality assurance include:
- GMP Certification Bodies: Ensure manufacturing standards are met or exceeded.
- Analytical Testing Labs: Contract laboratories such as Eurofins or SGS perform stability testing, batch release testing, and impurity profiling, ensuring quality before distribution.
Market Dynamics & Supplier Challenges
- Supply Chain Disruption Risks: The reliance on a few primary API suppliers can pose risks amidst geopolitical issues, regulatory changes, or raw material shortages.
- Pricing Pressures: Generic competition and regulatory scrutiny may influence supplier pricing strategies.
- Regulatory Variability: Suppliers must navigate complex regulatory environments, including FDA inspections, EMA approvals, or local country regulations, which impact manufacturing and supply continuity.
Conclusion
The supply chain for Gralise is characterized by a combination of original developer Activas Pharmaceuticals, complemented by specialized CMOs and high-quality API suppliers such as Teva, Cipla, and Dr. Reddy’s Laboratories. Distribution is managed by leading healthcare logistics companies, ensuring broad patient access.
Diversification within the supply chain mitigates risks but underscores the importance of robust quality control and regulatory compliance. For stakeholders, understanding the critical roles played by each supplier can aid in strategic planning, inventory management, and risk mitigation in the volatile pharmaceutical landscape.
Key Takeaways
- Primary Manufacturer: Activas Pharmaceuticals controls formulation and production of Gralise, leveraging proprietary controlled-release technology.
- APIs: Suppliers like Teva, Cipla, and Dr. Reddy’s are pivotal in ensuring a steady supply of high-quality gabapentin.
- Manufacturing & Packaging: Contract manufacturing organizations expand capacity and ensure adherence to regulatory standards.
- Distribution: Logistics giants McKesson and Cardinal Health enable widespread and timely access to Gralise.
- Risks & Opportunities: The supply chain’s reliance on a limited number of API sources requires vigilant risk management, while diversification offers stability.
FAQs
1. Who are the main manufacturers of Gralise?
Activas Pharmaceuticals is the primary manufacturer of Gralise, producing the extended-release gabapentin formulation. Contract manufacturing organizations (CMOs) also play significant roles in scale-up and packaging.
2. What are the key API suppliers for Gralise?
Leading API suppliers include Teva Pharmaceuticals, Cipla, and Dr. Reddy’s Laboratories, all of which provide high-quality gabapentin to support formulation manufacturing.
3. How is Gralise distributed globally?
Distribution is managed by healthcare logistics companies like McKesson and Cardinal Health, which supply pharmacies, hospitals, and clinics primarily in North America, with potential export to other regions.
4. What risks are associated with the supply chain of Gralise?
Risks include dependency on limited API suppliers, geopolitical factors affecting raw material availability, regulatory compliance challenges, and manufacturing disruptions.
5. How can stakeholders ensure supply stability of Gralise?
Diversifying API sources, maintaining strict quality control, engaging multiple CMOs, and establishing inventory buffers can mitigate supply risks.
Sources:
[1] U.S. Food & Drug Administration (FDA) Drug Approvals and Certificates.
[2] Activas Pharmaceuticals official website.
[3] Teva Pharmaceuticals API manufacturing overview.
[4] Industry reports on pharmaceutical supply chains, IQVIA, and EvaluatePharma.
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